YY/T 0774-2019 Active Industry standards-Medicine

YY/T 0774-2019 Ultrasound bone sonometers

Publish Date: 2019-07-24 Implement Date: 2021-08-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0774-2019

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical ultrasound, laser, and high-frequency instruments and equipment

ICS Name: Diagnostic equipment

Publish Date: 2019-07-24

Implement Date: 2021-08-01

Publisher: 国家药品监督管理局

Technical Committee: 全国医用电器标准化技术委员会医用超声设备分技术委员会(SAC/TC 10/SC 2)

Pages: 8 pages

Scope

本标准规定了超声骨密度仪的术语和定义、要求和试验方法。本标准适用于利用超声原理，通过测量骨骼中的声速和衰减特性来评价人体骨骼质量的超声骨密度仪。

Development Information

Drafting Units:

湖北省医疗器械质量监督检验研究院、合肥工业大学、中国科学院声学研究所、辽宁省医疗器械检验研究院、咸阳康荣信数字超声系统有限公司、湖北省食品药品监督管理局技术审评核查中心

Drafting Persons:

蒋时霖、王志俭、黄涛、彭虎、牛凤岐、朱承纲、矫强、杜文扬、柯虎、郑驰超、张安萍

Word Count: 12 Thousand words Pages: 8 pages

Replace the following standards

YY 0774-2010 Ultrasound bone sonometers

Referenced Standards

GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 15261-2008 Measurement methods for acoustic properties of ultrasonically tissue-mimicking materials GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB 9706.9-1997 Medical electrical equipment—Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment GB 9706.9-2008 Medical electrical equipment—Part 2-37:Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment JJF 1001-1998 General Terms in Metrology and Their Definitions JJF 1001-2011 General Terms in Metrology and Their Definitions YY/T 0865.1-2011 Ultrasonic—Hydrophone—Part 1:Measurement and characterization of medical ultrasonic fields up to 40 MHz YY/T 0939-2014 Ultrasound bone sonometers—Test method of broadband ultrasound attenuation(BUA) YY/T 1142-2003 Methods of measuring the frequency of medical diagnostic and monitoring ultrasonic equipment YY/T 1142-2013 Methods of measuring the frequency of medical ultrasonic equipment and probe YY/T 1420-2016 Environmental requirement and test methods for medical ultrasonic equipment YY/T 0865.1-2024 Ultrasonics—Hydrophones—Part 1:Measurement and characterization of medical ultrasonic fields

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